Our client in the pharmaceutical industry is seeking an experience QA Specialist to join their team on a long term contract at their Cambridge, MA location. This individual will be responsible for performing lot review/release activities for commercial drug substance, products and finished goods.
- Provide QA review and disposition of commercial lots of drug substance, drug product and finished goods
- Distribute work to QA staff to assure timely review of batch documentation
- Generate and/or review deviations and investigations to assess cGMP compliance of lots
- Lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance
- Initiate, monitor and complete change controls related to Quality topcs
- Review and approve supplier documents requiring Quality approval
- Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, Process Validation protocols/reports as applicable
- Provide training on department specific procedures and systems
- Collect data, calculate, and report on departmental performance metrics Identify and propose Quality process and system improvements. Lead improvement projects
- Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvements
- Lead Investigation teams and ensure proper close out and follow-up
- Review and approve process, assay, and other validation protocols and reports as applicable
- Prepare and review applicable sections of regulatory submissions
- Prepare and review applicable sections of the Annual Product Reviews
- BA/BS (or Master's) in any Life Science discipline preferred, and/or 8+ years experience in GxP Drug Manufacturing industry
- Understands and applies good working knowledge of quality and GMP principles.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint. Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
- Must display eagerness to learn and continuously improve.
- Positive work attitude that supports teamwork and continuous improvement.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgement, intellectual honesty, pragmatism, courage and conviction.
Sthree US is acting as an Employment Business in relation to this vacancy.